BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 3609026 · Received January 28, 2014

    Report

    Report Number
    1119279-2014-00018
    Event Type
    Injury
    Date Received
    January 28, 2014
    Date of Event
    December 23, 2013
    Report Date
    January 2, 2014
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SURGEON, THE LENS WAS NOT INJECTED SMOOTHLY INTO THE EYE. THE DELIVERY DEVICE HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDER EVALUATION. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LENS WAS REMOVED INTRAOPERATIVELY FROM THE PT'S LEFT EYE DUE A CAPSULE DAMAGE NOTED AFTER IOL INSERTION. VITRECTOMY WAS PERFORMED AND ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. THE PT IS EXPECTED TO CONTINUE TO IMPROVE ON TOPICAL STEROIDS AND NSAIDS FOR MILD CME. PLEASE REFERENCE MDR #: 1119279-2014-00017 FOR THE INTRAOCULAR LENS USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60278 VISCOJECT 1.8 DELIVERY SYSTEM MSS/IOL INSERTER/INJECTOR MSS MEDICEL AG LF604350 128103

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other AKREOS MICRO INCISION LENS (B+L)